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Eli Lilly Says Mirikizumab Meets Primary Endpoint In Patients With UC

Eli Lilly and Company (LLY) announced positive results from the late-stage study of its drug candidate mirikizumab in ulcerative colitis (UC).

UC is a chronic inflammatory disease of the large intestine, that affects the lining of the colon causing abdominal pain, bloody stools and incontinence.

Lilly said a 12-week phase III induction Study of mirikizumab in patients with moderate to severe ulcerative colitis, dubbed Lucent-1, met the the primary endpoint of clinical remission and all key secondary endpoints compared to placebo.

Clinical remission is met when inflammation of the colon is controlled or resolved, leading to normalization or near-normalization of symptoms such as stool frequency and bleeding.

The study achieved all its key secondary endpoints too, including reduced bowel urgency, clinical response, endoscopic remission, symptomatic remission and improvement in endoscopic histologic inflammation.

During the study, the incidence of treatment-emergent adverse events (AEs) and serious AEs among patients treated with mirikizumab was consistent with that of the previous Phase II study in UC and studies with the anti-IL-23p19 antibody class, Lilly said.

Lucent-2, a maintenance study of mirikizumab in patients who have completed the 12-week Lucent-1 induction study is ongoing.

"With these positive results, we look forward to the continuation of the maintenance study through 52 weeks in hopes of providing a new option to people living with UC," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly.

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